CAPD DISCONNECT Y SET

MDR report key: 3972780 · Received August 1, 2014

Report

Report Number: 1416980-2014-24999
Event Type: Malfunction
Date Received: August 1, 2014
Report Date: July 8, 2014
Manufacturer: BAXTER HEALTHCARE - MOUNTAIN HOME
Product Code: KDJ
PMA / PMN Number: K961825
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS CONDUCTED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, NO EVALUATION COULD BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem · 1

THIS IS A REPORT OF A HOME PATIENT (HP) WHO EXPERIENCED A CONNECTION ISSUE BETWEEN A CONTINUOUS AUTOMATED PERITONEAL DIALYSIS (CAPD) DISCONNECT Y-SET AND AN UNKNOWN TRANSFER SET. THIS OCCURRED DURING SETUP FOR CAPD THERAPY. THE HP REPORTED THAT THE Y-SET CONTINUALLY SPUN AROUND THE TRANSFER SET WITHOUT TIGHTENING. THE HP TRIED CONNECTING OTHER Y-SETS TO THE SAME TRANSFER SET, BUT EXPERIENCED THE SAME RESULT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 4 OF 9 FOR THE SAME PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
451050	CAPD DISCONNECT Y SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE - MOUNTAIN HOME		H12E31141

Patients

Seq	Age	Sex	Outcome	Treatment
1				UNKNOWN TRANSFER SET